Implantation of surgical implants with calcium sulfate

Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis – Bone

Reexamination Certificate

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C623S023510, C424S426000, C523S116000

Reexamination Certificate

active

06224635

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to the implantation of surgical implants by novel techniques that employ a surgical cement primarily composed of calcium forms of sulfate which have a solubility in water (pure water) at 25° C. in the range of about 0.5×10
−2
M to about 20×10
−2
M (hereinafter referred to as “CS”). There are at least three types of CS which are particularly useful in the present invention. These are calcium sulfate dihydrate, calcium sulfate hemihydrate and anhydrous calcium sulfate. Of these, the most preferred species is calcium sulfate hemihydrate. These novel techniques are described in detail below.
BACKGROUND OF THE INVENTION
The present invention is particularly of interest in the treatment of titanium or titanium alloy, such as Ti/Al/V alloy, implants, but may also be employed for the treatment of other metallic implants such as those of zirconium and tantalum, and coated metallic implants such as hydroxyapatite-coated titanium.
Dental Implants
Although the instant invention also contemplates orthopedic bone implants, it is equally applicable to dental bone implants.
There are basically two types of dental implants. Those that sit on top of the jaw bone, but under the gums, and those that fit into the jawbone similar to the root of a natural tooth. Each type offers solid, non-mobile support for replacement teeth which act and feel like natural teeth. Since both types are attached to the patient's jawbone they can provide distinct advantages over traditional methods of replacing missing teeth.
There are generally four types of dental bone grafts used: autograflts are those where the bone to be grafted to the jaw is taken, or harvested, from the patient's own body. The area where the bone is harvested from, known as the donor site, is usually the mouth or the hip. This is the paticnt's own bone and is very compatible with the paticnt's body. Autografts are generally the best graft technique and usually result in the greatest regeneration of nissing jawbone. Allografts are taken from human donors. Many countries have donor programs where you can specify that in the event of the patient's death, parts may be harvested from the patient's body to save or improve the life of others. Heart transplants are one type of allograft. This can represent one of the greatest “gifts” you can ever give. Bone obtained in this manor undergoes rigorous tests and sterilization. The patient's body “converts” the donor bone into the patient's natural bone, thereby rebuilding the patient's resorbed jawbone.
Xenografts are harvested from animals. The animal bone, most cormnonly bovine (cow), is specially processed to make it biocompatible and sterile. It acts like a “filler” which in time the patient's body will replace with natural bone. After this replacement process is complete dental implants may be placed to support teeth.
Alloplastic grafts are inert, man made synthetic materials. The modern artificial joint replacement procedure uses metal alloplastic grafts. For bone replacement a man made material that mimics natural bone is used. Most often this a form of calcium phosphate. Depending on how it is made, it may be “resorbable” or “non-resorbable”. That is, the patient's body may or may not replace the alloplastic graft with the patient's natural bone. In those cases where it is not replaced it acts as a lattice or scaffold upon which natural bone is built. In either case, the end result is to create enough bone for the placement of dental implants.
There are many implants available, each designed for a specific function. Most are made of titanium, an inert metal which has been proven to be effective at fusing with living bone, a process known as “osseointegration”. The cylindrical or screw type implant, called “root form”, is similar in shape to the root of a tooth with a surface area designed to promote good attachment to the bone. It is the most widely used design and generally placed where there is plentiful width and depth of jawbone. Where the jawbone is too narrow or short for immediate placement of root form implants the area may be enhanced with bone grafting to allow for their placement.
When the jawbone is too narrow and not a good candidate for bone grafting, a special narrow implant, called “plate form”, can be placed into the bone. In cases of advanced bone loss, the “subperiosteal” implant, may be prescribed. It rests on top of the bone but under the gums.
The actual implant procedure involves the surgical placement of the implant or implants, a healing period (osseointegration) and implant restoration to replace the missing tooth or teeth.
The treatment may be a cooperative effort between a surgical dentist who actually places the implant and a restorative dentist who designs, prescribes and inserts the final replacement teeth. Some dentists have advanced training and provide both of these services.
Root form implants are the closest is shape and size to the natural tooth root. They are commonly used in wide, deep bone to provide a base for replacement of one, several or a complete arch of teeth. After application of anesthetic, the patient's dentist will expose the area of the jawbone to be implanted and prepare the bone to accept the implant. The number of incisions and bone preparations depends upon the number of implants (and teeth) being placed. The implant is carefully set into place and the gums are closed with several stitches. The healing period usually varies from as few as three months to six or more. During this time osseointegration occurs. The bone grows in and around the implant creating a strong structural support. In fact, this bond can be even stronger than the original tooth's. When healing is complete, the patient's implant is uncovered and an extension or abutment is attached to it. Now the implant and abutment act as a solid unit ready to support the patient's new tooth or teeth.
Plate form implants are usually used when the bone is so narrow it may not be suitable for the root form implant and the area is not suitable for bone grafting. The plate form implant is flat and long so it can fit into the narrow jawbone. After application of anesthetic, the patient's dentist will expose the area of the jawbone to be implanted and prepare the bone to accept the shape of the implant. The number of incisions depends upon the number of implants being placed. The implant is carefully set into place and the gums are closed with several stitches. Like root form implants, there is usually a healing period for osseointegration, although some plate form implants are designed for immediate restoration.
With very advanced jawbone resorption there may not be enough bone width or height for the root form or plate form implant. In these cases the subperiosteal implant may be prescribed. The subperiosteal implant is custom made and designed to sit on top of the bone, but under the gums. There are two methods for its placement. After application of anesthetic, the patient's dentist will expose the jawbone and take an impression or model of the bone using special materials. This model is used by a dental laboratory to carefully create the custom implant to fit the patient's jaw. A second procedure is then carried out where the jawbone is exposed and the implant placed. The gums are closed with several stitches and replacement teeth are put into place.
For the “single surgery” method the patient's dentist will order a special CAT scan of the patient's jawbone Using the CAT scan data and advanced computer modeling techniques, a model of the patient's jawbone is constructed. This model is used by a dental laboratory to fabricate the custom subperiosteal implant to fit the patient's jaw. A surgical procedure is then carried out where the jawbone is exposed and the implant placed. The gums are closed with several stitches and the replacement teeth are put into place.
Bone Implants
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